Nearly two weeks after the detection of probable carcinogen at low levels of acid drugs, over-the-counter drugs are recalled.
The drug maker Apotex said Thursday that it has voluntarily recalled the 75 mg and 1
USA Today notes that acid-reducing drugs are generic versions of Zantac. The FDA has a full list of downloaded products here. Earlier this week, the Novartis-owned Sandos recalled bottles of ranitidine capsules with 30, 50 and 500 prescription medicines and abroad, British drug maker GlaxoSmithKline recalls ranitidine products in India and Hong Kong (not selling versions of the drug in the US). Several countries are taking steps to curb sales of ranitidine-containing drugs, ABC News reported.
The FDA has been testing Zantac and its generic versions, but has not yet requested withdrawal drug manufacturers. And Sanofi, which makes the Zantac brand, is still taking no steps.
"The FDA reports that levels of N-nitrosodimethylamine (NDMA) in ranitidine in preliminary tests barely exceed the amounts found in ordinary foods," says a Sanofi spokesman. "We work closely with the FDA and conduct our own robust investigations to ensure that we continue to meet the highest standards of safety and quality."
NDMA and two other cancer-causing agents also led to a broad reminder. blood pressure and heart medication from last year. This is blamed for manufacturing deficiencies, but experts say it is likely that enzymes in a person's body will react with the ranitidine molecule and actually create NDMA. See FDA updates here. (Read more drug recall stories.)
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